Kornimate/medical-research-clean huggingface dataset:
asp1517 phase 2 clinical trial - double-blind study of asp1517 for the treatment of anemia in chronic kidney disease patients not on dialysis-

Conditions: Anemia in Chronic Kidney Disease Patients Not on Dialysis

Summary: this study is to evaluate the safety and the dose-response of asp1517 in the treatment of anemia in non-dialysis chronic kidney disease (ckd) patients when asp1517 is applied intermittently.

to evaluate the safety and the dose-response of asp1517 on hemoglobin (hb) correction in the treatment of anemia in non-dialysis chronic kidney disease (ckd) patients when asp1517 is applied intermittently. patients will receive asp1517 three times a week (tiw) for first 6weeks. patients may have the second-randomization to tiw dosing or once-a-week (qw) dosing at week 6, 8, 10, 12, 14 or 16 if patients meet the criteria.

Eligibility criteria:
inclusion criteria: * chronic kidney disease with an estimated glomerular filtration rate (as calculated by the japanese gfr estimation equation) of =\<89 ml/min/1.73 m2, and not required dialysis for 3 months since study completion * the mean of two hb values at screening test and hb test (at least one week apart form the screening test) is \<10.0 g/dl, with a difference of ≤1.0 g/dl between the two values * both tsat\>=5% and ferritin \>=30 ng/ml at screening test * serum folate ≥4.0 ng/ml and vitamin b12 ≥180 pg/ml at screening test exclusion criteria: * proliferative retinopathy, age-related macular degeneration, retinal vein occlusion and/or macular edema that is considered to require treatment * immunological disease with severe inflammation as assessed by the investigator; even if the inflammation is in remission, the subject is excluded (e.g. lupus erythematosus, rheumatoid arthritis, sjogren's syndrome, celiac disease, etc). * having a history of gastric/intestinal resection considered influential on the absorption of the drug in the gastrointestinal tract or evidence of active gastroparesis. * uncontrollable hypertension (more than one third blood pressure values of diastolic bp \>100 mmhg within 16 weeks prior to screening test including) * congestive heart failure (nyha classification iii or higher) * having a history of hospitalization for stroke, myocardial infarction or lung infarction within 24 weeks before screening test * positive for any of the following: anti-hepatitis c virus antibody (anti-hcv ab); hepatitis b surface antigen (hbsag); or human immunodeficiency virus (hiv) * anemia other than anemia due to low/absent renal production of epo (e.g., iron deficiency anemia, hemolytic anemia, pancytopenia, etc) * using esa, anabolic androgenic steroid, testosterone enanthate or mepitiostane within 6 weeks before screening test

Keywords: chronic renal failure renal anemia asp1517
oxidative stress and inflammatory biomarkers in gaucher disease

Conditions: Gaucher Disease Type I; Oxidative Stress; Inflammation

Summary: the objective of this study is to evaluate oxidative stress and/or inflammation in patients with gaucher disease type i using a series of biomarkers and correlate with measurements of currently used diagnostic biomarkers.

we will determine oxidative stress and/or inflammation related biomarkers in whole blood and/or plasma in adult subjects with gaucher disease. fifteen milliliter blood sample will be collected during three independent visits over a period of approximately 3 months. these samples will be processed to separate plasma from red blood cells and frozen until assays are performed. standardized immunoassay methods and lc/ms based methods will be adopted to assay a series of biomarkers in these samples. these data will be correlated with currently used diagnostic biomarkers.

Eligibility criteria:
inclusion criteria: 1. all participants must be 18 years or older. 2. all enrollees must understand and cooperate with requirements of the study in the opinion of the investigators and must be able to provide written informed consent. 3. individuals with gaucher disease who are medically stable for participation in study in the opinion of the investigator. 4. gd subjects must be stable on a specific ert and/or srt therapy at a specific dose (for e.g. on a units/kg basis) for at least 2 years or be naïve to these therapies (no therapy for 2 years). 5. gd1 patients, who have had a change in therapy i.e. a change in dose or switch from one drug to another, can be enrolled after at least 6 months have elapsed since the change and is considered stable in the opinion of the clinician providing care to the patient. 6. all participants must not have taken antioxidants coenzyme q-10, vitamin c, or vitamin e for 3 weeks prior to the study. exclusion criteria: 1. medically unstable conditions in any group as determined by the investigators 2. concurrent disease; medical condition; or an extenuating circumstance that, in the opinion of the investigator, might compromise subject safety, study compliance, completion of the study, or the integrity of the data collected for the study. 3. females who are pregnant or lactating or of child-bearing age who are not using acceptable forms of contraception 4. history of asthma that is presently being treated 5. subjects who cannot or are unwilling to have blood drawn 6. unable to adhere to study protocol for whatever reason
improving diabetes care collaboratively in the community

Conditions: Diabetes

Summary: the purpose of this study is to determine whether a quality improvement intervention including rapid quality improvement, a chronic care model, and best practices improves diabetes care in community health centers and whether more intensive interventions enhance care further.

in 1998 the health resources and services administration's bureau of primary health care began the health disparities collaborative (hdc) to improve chronic disease management in community health centers (hc) nationwide. the hdc incorporates rapid quality improvement (qi), a chronic care model, and best practices. this study determines if the hdc improves diabetes care and whether more intensive interventions with additional learning sessions for health centers, provider training in behavioral change, and patient empowerment materials enhance care further.

Eligibility criteria:
inclusion criteria: - patients with diabetes age 18-75 years exclusion criteria: pregnant women -

Keywords: diabetes quality improvement community health center health disparities
functional and neurochemical brain changes bipolar depression

Conditions: Depression, Bipolar

Summary: the purpose of the research is to study brain structure, function and chemistry of patients with bipolar disorder who are receiving quetiapine or lithium, in order to better understand who benefits from treatment and why they respond to medications.


Eligibility criteria:
inclusion criteria - depressed bipolar patients (n=100; 15-20 patients/year): 1. patients will meet dsm-iv criteria for type i bipolar disorder, depressed, as determined by structured interview and best-estimate diagnostic procedures.138 2. patient has experienced a maximum of three documented affective episodes. 3. patient has been off medications for one week prior to study enrollment. 4. patient has a hamilton depression rating scale (hdrs) total score ≥20 5. patient is between the ages of 12 and 35 years. exclusion criteria: all subjects will be excluded from participation for the following reasons: 1. any chemical use disorder within 3 months. 2. any history of significant suicidality that would place the patient at risk to participate in this protocol. 3. current score ≥3 on item 3 of the hdrs-17 (suicide item) 4. any medical or neurological disorder that could influence fmri results. 5. a history of mental retardation or an estimated iq total score \<85. 6. an mri scan is contraindicated in the subject for any reason. 7. the patient lives \>100 miles from the university of cincinnati or cannot attend follow-up visits. 8. meets dsm-iv criteria for a bipolar mixed episode
differences in brain activity in the application of upper limb exercise tasks through virtual reality

Conditions: Stroke

Summary: this study aims to find out the difference in brain activity when performing upper limb exercise tasks through virtual reality-based motocog equipment for chronic stroke patients.

this study aims to find out the difference in brain activity when performing upper limb exercise tasks through virtual reality-based motocog equipment for chronic stroke patients. all participants will participate in tasks for upper limb exercise conducted for 26 minutes.

Eligibility criteria:
inclusion criteria: * patients aged 19 to 80 years * fma upper scores more than 25 and less than 58 * patients whose lesions do not include stimulation regions * patients with stroke with more than 6 months of onset * k-mmse scores more than 24 * patients who can grasp \& release exclusion criteria: * difficult to communicate due to severe language impairment. * accompanied by an existing serious neurogenic disease * existing significant psychiatric disorders such as major schizophrenia, bipolar disorder
effect of different concentrations of lidocaine in relieving pain in wide awake hand surgery using tumescence

Conditions: Lidocaine

Summary: lidocaine has been used along with adrenaline in tumescent anesthesia for a variety of procedures. this has been quite popular especially in wide awake surgery of the hand with no tourniquet. however, the appropriate lidocaine concentration is yet to be established. this randomized control trial will study the minimum effective lidocaine concentration in hand surgery using the tumescent technique.


Eligibility criteria:
inclusion criteria: 1. patients aged 16 to 60 years of either gender 2. patients with post burn/post traumatic contractures involving fingers \& palm 3. patients with nerve injury or flexor/extensor tendons injury distal to mid forearm. exclusion criteria: 1. patients with history of ischemic heart disease, chronic liver disease (alt/ast 40 iu/l), renal disease (creatinine 13mg/dl), bleeding disorder, peripheral arterial disease \& peripheral neuro3pathy . 2. surgical site infection . 3. history of allergic hypersensitivity to epinephrine or lidocaine.
extended study of prostate-specific membrane antigen antibody-drug conjugate in subjects with prostate cancer

Conditions: Prostate Cancer

Summary: prostate-specific membrane antigen antibody-drug conjugate (psma adc) 1301ext is an open-label, nonrandomized, phase 1 extension study of psma adc administered iv in subjects with progressive cmpc that has progressed after prior taxane therapy. subjects who have participated in psma adc 1301 and who, in the opinion of the pi, are likely to benefit from continued treatment with psma adc will be enrolled in psma adc 1301ext.


Eligibility criteria:
inclusion criteria: 1. subjects who have completed the psma adc 1301 study and who, in the opinion of the investigator, have derived benefit from treatment with psma adc. 2. a diagnosis of progressive, castration-resistant, metastatic prostate cancer. 3. prior chemotherapy regimens, one of which contains taxane. 4. eastern cooperative oncology group status of 0 or 1 exclusion criteria: 1. clinically significant cardiac disease or severe debilitation pulmonary disease 2. evidence of an active infection requiring ongoing antibiotic therapy 3. history of drug and/or alcohol abuse
the development, safety, and feasibility of an artificial intelligence-powered platform (nodeai) for real-time prediction of mediastinal lymph node malignancy during endobronchial ultrasound staging for lung cancer

Conditions: Lung Cancer; Non Small Cell Lung Cancer

Summary: lung cancer is the leading cause of annual cancer deaths globally, more than breast, prostate, and colon cancers combined. the staging of chest lymph nodes (lns) is a crucial step in the lung cancer diagnostic pathway because it aids in treatment decisions - whether a patient is a candidate for lung resection, chemotherapy, radiation, or multimodal treatments. endobronchial ultrasound transbronchial needle aspiration (ebus-tbna) is the current standard for chest nodal staging for non-small cell lung cancer (nsclc), and guidelines mandate that systematic sampling (ss) of at least 3 chest ln stations be routinely performed for accurate staging. unfortunately, ebus-tbna yields inaccurate results in 40% of patients, leading to misinformed treatment decisions. this proportion is much higher in patients with triple normal lns \[lns that appear normal on computed tomography (ct) scans, positron emission tomography (pet) scans, and ebus\], which have been found to have a \> 93% chance of being truly benign. this is because ebus-tbna is based on ultrasound, whose success highly depends on the skill of the person performing it (operator). when the operator makes an error, the entire procedure is jeopardized. this causes downstream delays in treatment due to repeated testing and ill-informed treatment decisions. over the past decade, the investigator has been conducting a series of research studies and trials: the development and validation of the canada lymph node score (clns) - a surgeon-derived semi-quantitative measure of ln malignancy; an artificial intelligence (ai)-based version of the clns to predict malignancy; and a fully autonomous ai that learned to predict malignancy directly from ultrasound images, to introduce ai to the decision-making pathway in nsclc. this resulted in the creation of an ai-powered software to predict malignancy in mediastinal lns of patients with lung cancer. the software is currently housed in cloud storage and its applications are latent - which means that ln images must be uploaded to the software, and results are received at a future time. in its current form, the software is not ready for clinical application due to this latency. in this project, the investigator aims to build a point-of-care device which will house the software (nodeai) and deliver real-time results to the surgeon, and this device will be tested in a clinical trial.


Eligibility criteria:
inclusion criteria: * patients ≥ 18 years of age diagnosed with suspected or confirmed nsclc based on ct and pet scans that are referred for chest staging by ebus-tbna * ct and pet scans completed exclusion criteria: * patients with cn0 disease and peripheral tumors and tumors \< 2 cm in diameter (those do not require chest staging)
desipramine in infantile neuroaxonal dystrophy (inad).

Conditions: Infantile Neuroaxonal Dystrophy

Summary: this is a research study to find out if clinically prescribed desipramine is effective at improving the symptoms and slowing the progression of infantile neuroaxonal dystrophy (inad) in affected children. participants will receive an initial oral dose of study drug once a day. this dose may be changed depending on response to study drug clinically collected data will be recorded for up to 5 years. investigators will also ask for participant permission to obtain a sample of child's skin biopsy from unused clinical sample previously collected for standard of care.

to be eligible participants must be able to swallow tablets the study drug is to be taken once daily schedule of events. day 0 - ecg and blood tests (4 ml or ¾ teaspoon) day 3 - ecg and blood tests (4 ml or ¾ teaspoon) day 7 - ecg and blood tests (4 ml or ¾ teaspoon) weeks 2, 3, 4, 8 \& 12. ecg and blood tests (4 ml or ¾ teaspoon) every 3 months for up to 5 years. .

Eligibility criteria:
inclusion criteria: * 03-17years. * any gender * confirmed homozygotes or compound heterozygotes of pathogenic mutation variant(s) in pla2g6 * confirmed homozygotes of pathogenic mutation in pla2g6 * documentation of clinical presentation (signs and symptoms of neurodegenerative process) of inad exclusion criteria: * patient has sign and symptom suggesting an ongoing acute or chronic illness such as fever of unknown origin or infection. * patient has a second genetic condition * parents are unable or unwilling to return for continued care for up to 12 months

Keywords: pediatric genetic disorder cognitive function neuro-muscular disorder pla2g6
contribution of anti-platelet antibodies identified with maipa assay in the demonstration of the auto-immune character of a thrombocytopenia at diagnosis

Conditions: Thrombocytopenia; Immune Thrombocytopenia; Myelodysplasia

Summary: immune thrombocytopenia (itp) is an autoimmune disease but, paradoxically, and unlike other autoimmune diseases, antiplatelet antibodies are not used either for the diagnosis of the disease or for its prognosis. itp is a diagnosis of exclusion retained after elimination of other pathologies leading to a thrombocytopenia. no major study has prospectively evaluated the diagnostic value of the presence of anti-platelet antibodies in the etiological investigation of a thrombocytopenia, nor the impact of platelet antibodies on the course of itp. the gold standard analysis for the determination of platelet antibodies, is the "monoclonal antibody immobilization of platelet antigens" assay (maipa), either direct to detect autoantibodies attached to platelets, or indirect to detect circulating antiplatelet antibodies. therefore, this work aims to study the contribution of the presence of anti-platelet antibodies detected in maipa to determine the autoimmune nature of a thrombocytopenia at diagnosis.


Eligibility criteria:
inclusion criteria: * patient over 18 years old; * patients with thrombocytopenia \<100 g/l, checked twice, having ruled out false thrombocytopenia by platelet aggregation and acute leukemia by smear; * no treatment started; * free, informed and written consent signed by the participant and the investigator (no later than the day of inclusion and prior to any review required by the research); * person affiliated or benefiting from a social security scheme. exclusion criteria: * secondary itp; * false thrombocytopenia; * patients who have been transfused with platelets for less than 7 days with efficacy; * patient treated for thrombocytopenia (48 hours of corticosteroid therapy is tolerated and is not an exclusion criteria); * patient with acute leukemia; * pregnant or breastfeeding woman; * false thrombocytopenia; * patient under guardianship, curatorship or any other legal protection regime.

Keywords: monoclonal antibody immobilization of platelet antigens assay maipa anti-platelet antibodies thrombopoietin
transform-hf ancillary mechanistic study

Conditions: Heart Failure

Summary: patients with heart failure are frequently treated with diuretics, including furosemide and torsemide, but it is not known if one is better than the other. the transform-hf trial is studying if torsemide is superior than furosemide for reducing the endpoint of death or hospitalization, but is not designed to study why. this ancillary study seeks to measure proteins in the blood and urine to help explain the underlying mechanism for why patients who take one of these diuretics may have better outcomes than patients who take the other.

patients who are enrolling in the transform-hf study or being prescribed torsemide or furosemide at hospital discharge will provide blood and urine at the time of study enrollment (within 72 hours of hospital discharge) and at 90 days (+/- one week) after hospital discharge.

Eligibility criteria:
inclusion criteria: * participation in the transform-hf trial or prescription of torsemide or furosemide * willing to provide blood and urine sample at enrollment and follow-up exclusion criteria: * inability or unwillingness to comply with the study requirements
efficacy of electroacupuncture in nmosd patients with pain: study protocol

Conditions: Neuromyelitis Optica Spectrum Disorders; Pain

Summary: abstract background neuropathic pain is a common complication in neuromyelitis optica spectrum disorder (nmosd), which seriously affects the quality of life of nmosd patients, with no satisfactory treatment. through the previous literature study and clinical observation, we found that acupuncture has good curative effect in the treatment of pain, especially electric acupuncture, but thestudies on acupuncture intervention in pain of nmosd are still scare. objective to evaluate the clinical efficacy of electroacupuncture on nmosd patients with pain. materials and methods in this exploratory randomized controlled study, nmosd patients with pain were recruited from march 21, 2022 to february 21, 2023. patients meeting the inclusion and exclusion criteria were randomly assigned to the electroacupuncture group (experimental group) and the sham electroacupuncture group (control group) by simple random method (envelope method) according to the inclusion order. totally, there are 20 patients enrolled. the experimental group received electroacupuncture therapy and the control group received sham electroacupuncture therapy. a total of 8 sessions were given twice a week for 30 minutes each. on the baseline, demographic information, medication history, specimens of routine blood, blood biochemistry, liver function, il - 6, tnf-α were collected, the brain, cervical and thoracic mri were perfected and collected, patients filled in the sf - mpq, nrs, sf - 36, sas, sds, edss. after the treatment, specimens of routine blood, blood biochemistry, liver function, il - 6, tnf-α were collected again, patients filled in the sf - mpq, nrs, sf - 36, sas, sd, edss. the main outcome indicators were sf-mpq, and the secondary outcome indicators were edss, nrs, sas, sds, sf-36, il-6, and tnf-α. conclusion this is the first exploratory randomized controlled study to evaluate the efficacy of electroacupuncture on pain in patients with nmosd. the study will provide clincial evidence of the practice of electroacupuncture on nmosd with pain. key words neuromyelitis optica spectrum disorders; pain; electroacupuncture


Eligibility criteria:
inclusion criteria: 1. people diagnosed as nmosd according to the international panel for nmo diagnosis (ipnd) criteria.\[21\] 2. nrs≥4. 3. people were treated with stable doses of biological therapy and/or prednisone, with no regimen adjustment within 30 days prior to enrollment. 4. people did not adjust any standard pain medication combinations, including antiepileptic drugs, antidepressants, and opioids, within 30 days before enrollment. 5. people or their families provided written informed consent. exclusion criteria: 1. people enrolled in other clinical studies. 2. people with low cognitive or mental ability. 3. people who became pregnant during the study period, breastfed, or planned to become pregnant. 4. people with serious diseases related to the heart, liver, kidney or hematopoietic system. 5. people with diabetic peripheral neuropathy.
a trial to compare the efficacy of two formulations of avotermin against placebo

Conditions: Scar Improvement

Summary: rn1006 has been developed as a stabilized formulation of avotermin which, when dosed once in pre-clinical studies in animals, has shown comparable scar improvement efficacy to the standard twice-dosed juvista formulation. the aim of this trial is to investigate the efficacy of rn1006 compared to juvista in a human volunteer model


Eligibility criteria:
inclusion criteria: * males and females aged 18-85 years who have given written informed consent * subjects with a body mass index within range 18-35 kg/m2 * subjects with clinically acceptable results for the laboratory tests specified in the trial protocol * female subjects using a highly effective method (s) of contraception exclusion criteria: * subjects who have a history of keloid scarring, surgery within one year of the first dosing area * subjects who have current scars, tattoos, birthmarks, mole within 3 cm of the area to be excised * subjects with any clinically significant medical condition or history of any condition which may impair wound healing

Keywords: healthy volunteers comparison of two formulations improvement of scar appearance